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Completed

NCT Number: NCT00959569

Esmolol in Cardiac Surgery

This large randomized double-blind clinical trial (esmolol vs placebo) will enroll patients undergoing cardiac surgery to study the additive cardiac protection of this therapeutic strategy.

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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vita-Salute University

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • end diastolic diameter >60 mm and/or an ejection fraction <50%
  • written informed consent
  • age >18 years

Exclusion criteria

  • previous unusual response to esmolol
  • inclusion in other randomized studies
  • esmolol administration in the previous 30 days
  • emergency operation

Treatment and study plan

esmolol

Drug

esmolol (1-3 mg/kg) during cardiac surgery

Other names: Beta-blocker; Beta blocker; breviblock

Placebo

Drug

normosaline (same ml of the study drug)

Primary outcomes

  1. Composite endpoint of number of dead patients and/or number of patients requiring prolonged ICU stay.

    Time frame: Hospital stay (approximately 2 weeks)

Secondary outcomes

  1. Number of patients with ventricular fibrillation after cardiopulmonary bypass

    Time frame: 30 days and 1 year

  2. Number of patients with low cardiac output syndrome

    Time frame: 30 days and 1 year

  3. Number of patients requiring post-operative inotropic support

    Time frame: 30 days and 1 year

  4. peak postoperative cardiac troponin level

    Time frame: 30 days and 1 year

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

Esmolol in Cardiac Surgery. A Randomized Controlled Trial With Clinical

Acronym: BREVI

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2009
Registry last updated
Oct 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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